510(k) K201634
K201634 is an FDA 510(k) premarket notification submitted by Chengdu Shifeng Medical Technology Co., Ltd. for the device "RG 3ml Medication Cartridge". The FDA issued a decision of Substantially Equivalent on March 26, 2021. The device falls under product code MRZ (Accessories, Pump, Infusion), a Class II device regulated under 21 CFR 880.5725.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 26, 2021
- Date Received
- June 16, 2020
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Accessories, Pump, Infusion
- Device Class
- Class II
- Regulation Number
- 880.5725
- Review Panel
- HO
- Submission Type